A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00692770Tipo: INTERVENTIONALInicio: 15 de ago de 2008Fin estimado: 28 de nov de 2014

Traducción no disponible, mostrando original

Resumen

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
Male or female subjects \>/= 18 years of age
Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
For subjects undergoing surgical resection pathology proven complete removal of tumor.
Intermediate or High Risk of recurrence as assessed by tumor characteristics.
Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
ECOG Performance Status of 0.
Adequate bone marrow, liver and renal function

Criterios de exclusión

Recurrent HCC
Child-Pugh score 7 points with presence of ascites.
Low risk of recurrence after curative treatment
History of cardiovascular disease
History of HIV infection
Active clinically serious infections (\> grade 2 NCI-CTCAE version 3.0)
Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
Subjects with evidence or history of bleeding diathesis
Subjects undergoing renal dialysis
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry as defined by the signing of informed consent..
Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
Encephalopathy
History of GI bleeding within 30 days of randomization.
Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
Liver transplantation, this includes patients on a transplant list with the intention to transplant

Intervenciones

drug

Nexavar (Sorafenib, BAY43-9006)

Sorafenib 400 mg twice daily (BID)

drug

Placebo

Placebo 2 tablets twice daily (BID)

Ubicaciones

Pilar, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBayer

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